The Recall Desk

Archive

March 2022 recalls

662 recalls were announced in March 2022.

What the numbers show

Critical
25
Severe
167
High
312
Moderate
150
Low
8

Of the 662 recalls this month scored against our rubric, 4% are Critical, 25% are Severe.

401–500 of 662

  • SevereNHTSA·22V159000·2022-03-15

    Great Dane Recalls 2022 Trailers Due to Loose Suspension Bolts

    Great Dane is recalling 2022 Champion and Everest trailers because suspension bolts were not properly tightened, posing a crash risk.

    Product
    GREAT DANE — GREAT DANE CHAMPION, EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V158000·2022-03-15

    Kia Recalls 2014-2016 Cadenza for Windshield Bonding Defect

    Kia is recalling 2014-2016 Cadenza vehicles because the front windshield may not be properly bonded, posing a risk of detachment.

    Product
    KIA — KIA CADENZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V154000·2022-03-14

    2021–2022 Dodge Durango and Jeep Grand Cherokee Steering Recall

    Chrysler is recalling 2021–2022 Dodge Durango and 2022 Jeep Grand Cherokee vehicles due to steering gear defect. The rack bar may have been insufficiently hardened, potentially causing loss of steering control.

    Product
    JEEP — JEEP, DODGE GRAND CHEROKEE 4XE, DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V155000·2022-03-14

    2020 Audi S7 and Related Models: Fuel Gauge Malfunction Recall

    Volkswagen Group (Audi) is recalling certain 2019-2022 A6, A7, S6, S7, RS6 Avant, and RS7 vehicles because the fuel level sender may stick, causing inaccurate fuel gauge readings that could lead to engine stalls and crash risk.

    Product
    AUDI — AUDI A6, A7, A6 ALLROAD, S7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V153000·2022-03-11

    Thomas Built Buses Recalls Saf-T-Liner EFX School Buses for Seat Bolt Defect

    Daimler Trucks North America is recalling 2020-2023 Thomas Built Buses Saf-T-Liner EFX school buses because passenger seat mounting bolts may break, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V150000·2022-03-11

    Ford Recalls F-150, Expedition, Navigator for Brake Master Cylinder Leak

    Ford is recalling 2016-2018 F-150, 2016-2017 Expedition, and Navigator vehicles because a brake master cylinder leak may reduce front brake function and increase crash risk.

    Product
    FORD — FORD, LINCOLN F-150, EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V143000·2022-03-11

    Forest River 2022 Travel Trailers Recalled for Coupler Weld Defect

    Forest River is recalling certain 2022 travel trailers due to improperly welded couplers that may cause trailer separation from the tow vehicle. Dealers will replace the coupler at no charge.

    Product
    FOREST RIVER — FOREST RIVER, EAST TO WEST XLR TOYHAULER, SILVER LAKE, VIBE, DELLA TERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E018000·2022-03-11

    Norco Frames Recalled for Improperly Welded Couplers

    Norco Industries is recalling certain frames with Model CA-5400 couplers due to improper welding that may cause trailer separation.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V144000·2022-03-11

    Keystone Travel Trailers Recalled for Faulty Wiring Disabling Safety Alarms

    Keystone is recalling 2021-2022 Sprinter and Bullet models plus multiple 2022 travel trailer and fifth-wheel variants due to faulty solar controller wiring that can disable carbon monoxide and propane gas detectors.

    Product
    KEYSTONE — KEYSTONE BULLET, MONTANA HIGH COUNTRY, COUGAR, CARBON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V151000·2022-03-11

    2021-2022 Ford Edge Rearview Camera Software Error Causes Display Failure

    Ford is recalling 2021-2022 Edge vehicles with a software error that may cause the rearview camera to display a blank or distorted image. This reduces driver visibility behind the vehicle, increasing crash risk.

    Product
    FORD — FORD EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V145000·2022-03-11

    2020-2022 Ford F-59 Steering Shaft Bolt May Loosen, Increasing Crash Risk

    The bolt securing the intermediate steering shaft to the steering gear box may become loose, potentially causing loss of steering control and increased crash risk. Ford is replacing the bolts for free.

    Product
    FORD — FORD F-59
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V149000·2022-03-11

    2022 Ford Escape High Voltage Battery Failure Causes Drive Power Loss

    The high voltage battery in 2021-2022 Ford Escape and 2022 Lincoln Corsair hybrid vehicles may fail, causing sudden loss of drive power and increasing crash risk.

    Product
    FORD — FORD, LINCOLN ESCAPE, CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-03102022-01·2022-03-10

    Trader Joe's Chicken Salad Recalled for Potential Hard Plastic Contamination

    USDA FSIS issued a public health alert for Trader Joe's Crunchy Slaw with Chicken due to potential hard plastic in the dressing. No illnesses have been reported.

    Product
    R & G Fine Foods, Inc. — FSIS Issues Public Health Alert for Chicken Salad Products Containing FDA-Regulated Dressing that has been Recalled due to Foreign Material Contamination
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·22E017000·2022-03-10

    Chrysler Recalls Mopar ABS Modules for Electronic Stability Control Defect

    Chrysler is recalling Mopar Anti-lock Brake System (ABS) Control Modules because software may prevent the Electronic Stability Control (ESC) malfunction light from illuminating, increasing crash risk.

    Product
    ELECTRONIC STABILITY CONTROL (ESC) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V141000·2022-03-10

    GMC Recalls 2022 Hummer EV Pickup for Taillight Software Defect

    General Motors is recalling 2022 GMC Hummer EV Pickups because taillight software may cause lights to fail or stay on, increasing crash risk.

    Product
    GMC — GMC HUMMER EV PICKUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0815-2022·2022-03-09

    Vadilal Quick Treat Custard Apple Pulp Recalled for Salmonella

    Vadilal Industries is recalling Quick Treat Custard Apple Pulp (1kg packages, UPC 8901777282168) due to potential Salmonella contamination. Approximately 997 cases were distributed nationwide to retail stores.

    Product
    Vadilal Quick Treat Custard Apple Pulp Net Wt, 1kg/35.27-oz. Product code FPEP44302 UPC:8901777282168 Best Before September 2023
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2022·2022-03-09

    COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results

    Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    6 states
  • SevereNHTSA·22V139000·2022-03-09

    Maintainer Recalls 2021-2022 Crane Trucks Due to Fire Risk

    Maintainer is recalling 2021-2022 crane-equipped truck bodies because an inductor may contact the frame, causing an electric arc and increasing fire risk.

    Product
    MAINTAINER — MAINTAINER CRANE W/ SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0806-2022·2022-03-09

    Whole Foods Market Vanilla Shortbread Cookies Recalled Due to Undeclared Egg

    Whole Foods Market Vanilla Shortbread Cookies are recalled due to undeclared egg allergen. The 23 units distributed in Washington D.C. with pack date 1/20/22 may pose serious risk to consumers with egg allergies.

    Product
    Whole Foods Market Vanilla Short Bread Cookies packaged in clear plastic container with a white scale label applied PLU 66705
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0662-2022·2022-03-09

    Philips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure

    A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617
    Category
    Medical Device
    Distribution
    13 states
  • SevereCPSC·22094·2022-03-09

    Olight M2R Pro and Warrior Mini Flashlights Recalled for Burn Hazard

    Olight is recalling about 215,100 M2R Pro and Warrior Mini flashlights because they can turn on accidentally and overheat while stored in a holster or pocket, creating a burn hazard. The company has received 127 reports of unintended activation with 22 burn injuries, including three second-degree burns.

    Product
    M2R Pro and Warrior Mini Flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0813-2022·2022-03-09

    Enoki Mushrooms Recalled Due to Listeria monocytogenes Contamination Risk

    GOLDEN MEDAL MUSHROOM INC is recalling Xuerong brand enoki mushrooms contaminated with Listeria monocytogenes. The affected product was distributed in California, Texas, and Illinois.

    Product
    Enoki Mushrooms, brand Xuerong, net wt. 150 g/ 5.25200g/7.05-ounce packages, UPC 6953150110157. 34 0er carton.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0663-2022·2022-03-09

    Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled

    Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0680-2022·2022-03-09

    Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use

    Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0712-2022·2022-03-09

    KWIK-STIK Quality Control Kit Recalled for Incorrect Antibiotic Susceptibility

    Microbiologics Inc is recalling KWIK-STIK quality control kits containing Enterococcus faecalis because certain lots are susceptible to Gentamicin Synergy when they should be resistant. The defect could affect laboratory testing accuracy.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22093·2022-03-09

    Danby Free-Standing and Slide-In Ranges Recalled for Tip-Over Hazard

    Danby is recalling about 1,700 free-standing and slide-in electric and gas ranges because the anti-tip-over bracket may not be securely installed, creating a tip-over hazard and risk of burn injuries when heavy objects are placed on an open oven door.

    Product
    Danby brand free-standing and slide-in electric and gas ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2022·2022-03-09

    da Vinci Surgical Cannula Reducer Metal Tip May Dislodge During Surgery

    Intuitive Surgical is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer because the metal tip may dislodge from the plastic shaft. If unnoticed, additional surgery may be needed, or energy leakage could cause tissue damage.

    Product
    da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2022·2022-03-09

    Titanium Toe Joint Implant Contains False MR Compatibility Claims

    BioPro recalled titanium toe implants due to incorrect claims in documentation about magnetic resonance (MR) compatibility testing that was never conducted. The FDA issued a Class II recall to address the misleading safety information.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22096·2022-03-09

    Honda Talon 1000 ROVs recalled for engine failure and crash risk

    Honda is recalling approximately 32,000 Talon 1000 recreational off-highway vehicles from 2019-2021 because a loose intake funnel band screw can enter the engine and cause sudden failure, potentially leading to loss of control and crashes.

    Product
    Honda Talon 1000 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2022·2022-03-09

    Brasseler K-WIRE surgical instruments recalled for unsealed packaging

    Brasseler USA is recalling 231 units of K-WIRE Double Trocar Smooth surgical instruments due to unsealed packaging that may compromise sterility.

    Product
    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2022·2022-03-09

    BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance

    Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.

    Product
    BUTLER Clear Dip, 12 bottles/case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2022·2022-03-09

    K2M Everest MI XT Outer Dilators recalled for manufacturing defect

    K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.

    Product
    Everest MI XT Outer Dilator, Catalog Number 5101-90168
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2022·2022-03-09

    QC Control Panels Fail Shelf Life Stability Test at 24 Months

    Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.

    Product
    Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0808-2022·2022-03-09

    Wegmans Roasted Garlic Hummus Recalled for Potential Plastic Contamination

    Wegmans brand Roasted Garlic hummus may contain blue plastic pieces. Affected units were distributed to MD, MA, NJ, NY, NC, PA, and VA.

    Product
    Wegmans brand Roasted Garlic hummus; NET WT 32 OZ (2 LB) 908 g; packaged in clear plastic container with a clear plastic snap lid; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0814-2022·2022-03-09

    Great Value Tortilla Chips Recalled Due to Metal Contamination

    Great Value Restaurant Style White Corn Tortilla Chips are being recalled due to potential metal contamination. Affected products have lot codes 122051## or 123051## with a best-by date of May 23, 2022.

    Product
    Great Value Restaurant Style White Corn Tortilla Chips, Net St. 13 oz. UPC 78742-11453. Distributed By: Walmart, Inc. Bentonville, AR 72716.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0804-2022·2022-03-09

    Carrot Cake Soft Bake Cookies Recalled for Undeclared Pecan Allergen

    J & M Foods is recalling Favorite Day Carrot Cake Soft Bake Cookies because pecans are listed as an ingredient but not declared in the allergen warning statement, posing a risk to consumers with pecan allergies.

    Product
    Favorite Day Carrot cake soft bake cookies Net Wt 8 oz. (227g) UPC 0 885239 25803 3 packaged in gable top carton 6 units per case
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-0810-2022·2022-03-09

    Food products from Family Dollar stores recalled due to rodent activity

    Food products from Family Dollar retail stores in six southern states are being recalled due to potential exposure to rodents and rodent activity in a distribution center. Consumers should not consume affected products.

    Product
    Food products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0714-2022·2022-03-09

    Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility

    Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2022·2022-03-09

    AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples

    Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.

    Product
    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0689-2022·2022-03-09

    Titanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims

    BioPro Titanium MPJ toe implants are recalled due to false documentation claiming MRI safety testing that was never performed. Patients should not undergo MRI with this implant until properly evaluated.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error

    BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2022·2022-03-09

    Titanium MPJ Toe Implant Recalled for Incorrect MR Safety Labeling

    BioPro is recalling Titanium MPJ toe implants (Lot 125651) with inaccurate labeling claiming MR compatibility when the implant has not been tested for magnetic resonance safety. Patients should consult their physician before MRI.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implant documentation incorrectly claims MRI safety testing that was never conducted. The implant is not proven safe for MRI use.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2022·2022-03-09

    Surgical knee navigation implant recalled over sterilization failures

    Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.

    Product
    NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2022·2022-03-09

    Stryker medical implant recalled for manufacturing defect in barrier layer

    Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.

    Product
    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2022·2022-03-09

    Helix Elite Molecular Standards recalled due to shelf life test failure

    Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0812-2022·2022-03-09

    Dietary supplements from Family Dollar stores recalled for rodent exposure

    Family Dollar dietary supplements were recalled due to potential rodent exposure at a distribution center. The recall affects products from six southern states purchased from January 2021 onward.

    Product
    Dietary supplements purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, including but not limited to vitamins, herbal and mineral supplements
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0803-2022·2022-03-09

    Ice Cream Mislabeled: Black Walnut Packed in Cookie Dough Container

    Signature Select Black Walnut Ice Cream was incorrectly packaged in containers labeled as Cookie Dough, which do not declare nuts as an allergen. The product lid correctly identifies the actual flavor.

    Product
    Signature Select Cookie Dough Ice Cream Vanilla Flavored ice cream with chocolate flavored chips and chunks of chocolaty chip cookie dough. Artificial Flavor added. 1.5 qt. paper container. 6 retail units per case. UPC 2113008803 Some container were filled with Black Wal
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0805-2022·2022-03-09

    Ardent Mills All Purpose Flour Recalled for Salmonella Contamination

    Ardent Mills has recalled 1,450 bags of Hotel and Restaurant All Purpose Flour due to Salmonella detected in testing. The affected product was distributed in Iowa and Ohio.

    Product
    Ardent Mills Hotel and Restaurant All Purpose Flour - AA, 50 lb. (22.68kg) bag, UPC 6 78008 00053 9, Ardent Mills, Denver, CO 80202. Milled in Alton, IL.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0705-2022·2022-03-09

    K2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect

    K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.

    Product
    Everest MI XT Inner Dilator, Catalog Number 5101-90167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2022·2022-03-09

    Abbott Alinity m reaction units risk detachment during transport

    Abbott Molecular is recalling 3063 kits of Alinity m Integrated Reaction Units due to potential detachment of reaction vessels from the unit cap during transport. No injuries have been reported.

    Product
    Alinity m Integrated Reaction Units (IRU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2022·2022-03-09

    Digital Angiography System Generators May Emit Excessive X-Ray Radiation

    Shimadzu Medical Systems is recalling Digital Angiography System generators due to potential excessive x-ray radiation in fluoroscopic mode. Installation issues may cause radiation dose rates to exceed safe limits.

    Product
    Digital Angiography System Bransist safire Generator Model D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0711-2022·2022-03-09

    Bronchial Microbiology Brush Labeling Error—Cleared Only for Gastrointestinal Use

    Hobbs Medical is recalling 38,357 Bronchial Microbiology Brushes due to labeling that incorrectly indicates bronchial use. The device is cleared only for gastrointestinal use.

    Product
    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the shea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2022·2022-03-09

    Helix Elite Molecular Reference Standard Recall for Failed Shelf-Life Testing

    Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2022·2022-03-09

    Titanium Toe Implants Recalled for Incorrect MRI Safety Labeling

    BioPro Titanium MPJ toe implants are recalled because labeling incorrectly claims MRI safety without actual testing. Patients should consult their physician before undergoing MRI procedures.

    Product
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2022·2022-03-09

    OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect

    Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.

    Product
    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2022·2022-03-09

    Digital Angiography System generator may exceed safe radiation dose rates

    Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.

    Product
    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0681-2022·2022-03-09

    Acorn stairlifts recalled due to inadequate seat structural strength

    Acorn Stairlifts Inc. is recalling multiple stairlift models because the seats may not have adequate strength to consistently support users during continued use, creating a fall hazard.

    Product
    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2022·2022-03-09

    BioPro Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for MRI.

    Product
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Statements

    BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2022·2022-03-09

    Helix Elite Molecular Standard Fails FDA Shelf-Life Stability Testing

    Microbiologics Inc. recalls Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071 molecular standard after real-time shelf life testing failed at 24 months. The product was distributed nationwide and internationally.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2022·2022-03-09

    Lacrimedics Collagen Plugs recalled for potential sterility seal compromise

    Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.

    Product
    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2022·2022-03-09

    Regard TOTAL HIP surgical implant recalled due to incorrect product identification labeling

    ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.

    Product
    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0697-2022·2022-03-09

    Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure

    Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.

    Product
    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2022·2022-03-09

    Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations

    Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0642-2022·2022-03-09

    Alprazolam Tablets 1mg Recalled for CGMP Deviations

    Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0644-2022·2022-03-09

    HEB Isopropyl Alcohol First Aid Antiseptic Label Mix-Up Recall

    HEB 50% Isopropyl Alcohol First Aid Antiseptic bottles contain 3% Hydrogen Peroxide instead due to a label mix-up. The front label incorrectly identifies the product as isopropyl alcohol when the contents are actually a hydrogen peroxide topical solution.

    Product
    HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0637-2022·2022-03-09

    Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

    Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.

    Product
    Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0641-2022·2022-03-09

    Over-The-Counter Drug Products Sold by Family Dollar Stores Recalled

    Dollar Tree Distribution is recalling all over-the-counter drug products sold by Family Dollar retail stores in six states due to potential rodent exposure at a distribution center.

    Product
    All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0713-2022·2022-03-09

    Dexamethasone Elixir Recalled for Impurities Above Permissible Levels

    Morton Grove Pharmaceuticals is recalling Dexamethasone Elixir USP 0.5 mg/5 mL nationwide due to unknown impurities found at higher than permissible levels in affected lots.

    Product
    Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2022·2022-03-09

    70% Isopropyl Alcohol First Aid Antiseptic Contains Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen due to undeclared ethyl alcohol in the product. The recall affects bottles distributed nationwide.

    Product
    70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0703-2022·2022-03-09

    QC Control Sets for GBS Testing Recalled Due to Contamination

    Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.

    Product
    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Gro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2022·2022-03-09

    Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing

    A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.

    Product
    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Grou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2022·2022-03-09

    TSM Brands Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol bottles nationwide because the product contains undeclared ethyl alcohol that is not identified on the label.

    Product
    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0679-2022·2022-03-09

    DARCO Locking Bone Plate System Recalled for Incorrect Manufacturing and Distribution Dates

    Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.

    Product
    The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The var
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0639-2022·2022-03-09

    Olanzapine 10 mg tablets recalled due to cGMP deviations

    Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.

    Product
    OLANZAPINE — OLANZAPINE (OLANZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2022·2022-03-09

    LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification

    A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.

    Product
    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling

    BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V134000·2022-03-08

    Mercedes-Benz Recalls Metris Vans Due to Fuel Hose Leak Risk

    Daimler Vans USA is recalling 2017-2022 Mercedes-Benz Metris vehicles because insecure fuel hose connections may cause leaks, increasing fire risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V131000·2022-03-08

    Mercedes-Benz Recalls 2021 Sprinter Vans Due to Torsion Bar Assembly Error

    Daimler Vans USA is recalling 2,153 2021 Mercedes-Benz Sprinter vans because an incorrectly installed shim on the torsion bar may fail, causing loss of vehicle stability and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 4500, SPRINTER 3500, SPRINTER 2500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V136000·2022-03-08

    Triple E Recalls Motorhomes Due to Missing Refrigerator Exhaust Deflectors

    Triple E is recalling 2010-2014 Unity, Libero, and Serenity motorhomes because missing refrigerator exhaust deflectors allow heat to overheat the wood frame, posing a fire risk.

    Product
    TRIPLE E — TRIPLE E SERENITY, LIBERO, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V135000·2022-03-08

    2022 Forest River Cardinal travel trailers recalled for electrical fire risk

    Forest River is recalling certain 2022 Cardinal and related travel trailers due to a loose wire cord at the 50AMP shore power inlet that may cause an electrical short and fire.

    Product
    COACHMEN — COACHMEN, FOREST RIVER FREEDOM EXPRESS, CHEROKEE, SABRE, APEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V138000·2022-03-08

    Terex Recalls 2016-2021 Aerial Devices Due to Emergency Stop Defect

    Terex is recalling 2016-2021 OM, Optima-HRX, and TCX aerial devices because emergency stop controls may fail to stop all boom functions, increasing injury risk.

    Product
    TEREX — TEREX OPTIMA TCX, OPTIMA HRX, OM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V132000·2022-03-07

    Ubco Recalls 2021-2022 2X2 ADV Motorcycles Due to Wheel Hub Gear Defect

    Ubco is recalling 2021-2022 2X2 ADV motorcycles because a wheel hub gear may loosen and contact the motor, potentially causing the wheel to seize and increasing crash risk.

    Product
    UBCO — UBCO 2X2 ADV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V130000·2022-03-07

    Yamaha Recalls 2021-2022 MT-09 and Tracer 9 GT Motorcycles for ECU Defect

    Yamaha is recalling 2021-2022 MT-09 and Tracer 9 GT motorcycles because improper ECU programming may cause engine stalls or limit throttle response, increasing crash risk.

    Product
    YAMAHA — YAMAHA MT-09, TRACER 9 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V126000·2022-03-04

    Midwest Automotive Designs Recalls 2018-2020 Sprinter Vans Due to Fire Risk

    Midwest Automotive Designs is recalling 2018-2020 Passage, Weekender, and Daycruiser Sprinter Vans because a circuit board may overheat and cause a fire.

    Product
    MIDWEST AUTOMOTIVE DESIGN — MIDWEST AUTOMOTIVE DESIGN WEEKENDER, PASSAGE, DAYCRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·008-2022·2022-03-04

    Boyd Specialties Recalls Jerky Products Due to Possible Listeria Contamination

    Boyd Specialties is recalling approximately 1,634 pounds of ready-to-eat jerky products due to possible Listeria monocytogenes contamination. The products were shipped to retail locations in eight states.

    Product
    Boyd Specialties LLC — Boyd Specialties, LLC Recalls Jerky Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·22V125000·2022-03-04

    Mercedes-Benz Recalls 2020-2021 Models for Rear Brake Caliper Fastener Issue

    Mercedes-Benz is recalling 2020 AMG CLA 35 and 2021 GLA 250 vehicles because loose rear brake caliper fasteners may reduce braking performance or cause parts to detach.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250, AMG CLA35
    Category
    Vehicle
    Distribution
    Distributed nationwide

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